【 文献重点摘要 】

Background

Safety and efficacy of botulinum toxin A for glabellar line (GL) treatment are well established. Currently approved formulations require reconstitution before injection.

Objectives

The authors sought to assess 6-month efficacy, safety, and patient satisfaction of new ready-to-use abobotulinumtoxinA solution for injection (ASI) in patients with moderate-to-severe GL at maximum frown.

Methods

The authors conducted a phase 3, double-blind, randomized, placebo-controlled trial (NCT02353871). Patients (N = 185) were randomized (2:1) to receive ASI 50 U or placebo. GL severity was evaluated at days 8, 15, 29, 57, 85, 113, 148, and 183 employing a 4-point scale for investigator’s live assessment (ILA) and subject's self-assessment (SSA). Primary endpoint was ILA of GL at maximum frown at day 29, and secondary endpoints were ILA and SSA of GL at maximum frown (all time points), patient satisfaction with GL appearance, time to onset, and duration of action.

Results

Responder rates were significantly higher for ASI vs placebo (88.3% vs 1.4%; P < 0.0001) at day 29 by ILA and all time points by ILA (P < 0.0001-0.0441) and SSA (P < 0.0001-0.0036). Sixty percent of patients reported onset of treatment response on or before day 3 (P < 0.0001 vs placebo), and in 5% of patients, efficacy by ILA lasted 6 months (day 183; P = 0.0441 vs placebo). Patient satisfaction rates were significantly higher for ASI vs placebo at all visits (P < 0.0001). Safety was comparable with the known abobotulinumtoxinA profile.

Conclusions

ASI was significantly efficacious for improving moderate or severe GL vs placebo by investigator and patient assessment. ASI was associated with high patient satisfaction, a long duration of action, and comparable safety profile to abobotulinumtoxinA.

背景

A型肉毒杆菌毒素治疗眉间纹(GL)的安全性和有效性是公认的。目前批准的配方需要在注射前进行重组。

目的

评价新的即用A型肉毒毒素注射液(ASI)治疗中重度GL患者6个月的有效性、安全性和患者满意度。

方法

作者进行了3期双盲、随机、安慰剂对照试验(NCT02353871)。患者(N=185)随机(2：1)接受AS I50U或安慰剂治疗。分别在第8、15、29、57、85、113、148和183天采用4分调查员生活评估量表(ILA)和受试者自我评估量表(SSA)评估GL严重程度。主要终点是GL在第29天最大皱眉时的ILA，次要终点是GL最大皱眉时的ILA和SSA(所有时间点)，患者对GL外观、发病时间和行动持续时间的满意度。

结果

用药后第29天，用药组有效率(88.3%)明显高于安慰剂组(1.4%；P<0.0001)，各时间点用药组(P<0.0001~0.0441)和用药组(P<0.0001~0.0036)的有效率均显著高于安慰剂组。60%的患者报告在第3天或之前开始治疗反应(与安慰剂相比，P<0.0001)，在5%的患者中，ILA的疗效持续6个月(第183天；与安慰剂相比，P=0.0441)。在所有就诊中，ASI组的患者满意率明显高于安慰剂组(P<0.0001)。安全性与已知的A型肉毒毒素相当。

结论

研究人员和患者评估表明，与安慰剂相比，ASI对改善中、重度GL有显著效果。ASI与较高的患者满意度、较长的作用时间和与A型肉毒毒素相当的安全性相关。